Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603311
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Finite Treatment of Hepatitis Delta with Bulevirtide Identification of Biomarkers Associated with Sustained Control of HDV Infection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Finite Treatment of Hepatitis Delta with Bulevirtide Identification of Biomarkers Associated with Sustained Control of HDV Infection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUL-STOP
Brief Summary:
Finding biomarkers for stopping bulevirtide treatment of patients with hepatitis delta
Detailed Description:
This is a multicenter prospective single-arm discontinuation study in which patients who have been treated with BLV for at least 48 weeks are intentionally discontinued from the treatment
Currently the treatment duration has not yet been defined and BLV can be given as long as a clinical benefit is evident In patients with advanced liver disease maintenance treatment is recommended by most experts
In pivotal phase II studies in which patients were treated with BLV for 24-48 weeks some patients 10-20 maintained a reduced HDV viral load with normal liver enzymes after the end of treatment Wedemeyer et al 2018 2019 2020 However it is completely unclear which patients are able to control HDV infection without antiviral therapies Biomarkers would be needed to identify patients in whom treatment can stopped safely This is even more important because HDV flares can be life-threatening in the event of a relapse after stopping BLV Thus the main aim of this study is to explore biomarkers in blood and liver associated with maintained virological control after at least 24 weeks of HDV-RNA levels below 100 IUml with at least 2 tests plus one test at screening on BLV treatment The investigators hypothesize that biomarker-based criteria should be able to identify patients with a sustained immune control This information would be highly relevant to personalize treatment duration or stopping of BLV treatment could reduce long-term disease burden would enable safer treatments and also reduce treatment costs Within the proposed systematic unbiased study the investigators follow a broad screening for biomarkers that may be suitable to discriminate in a first step between patients that will experience a virological relapse HDV RNA above 1000 IUml after discontinuation of treatment and those without
The investigators plan to include 20 patients in this study These patients have to have received BLV treatment for at least 48 weeks and have to show HDV-RNA levels below 100 IUml in two repeated tests plus one test at screening for at least 24 weeks while still being on treatment Treatment will be stopped with the beginning of the study and patients will be followed for 48 weeks It is expected that up to 14 patients will maintain HDV-RNA control HDV-RNA below 1000 IUml The other patients are expected to experience a virological relapse Treating physicians should consider to re-initiate BLV at HDV-RNA levels of above 1000 IUml
The aim of the study is to identify biomarkers that are associated with maintained virological response and could therefore be further investigated as predictive markers for treatment response
Currently the treatment duration has not yet been defined and BLV can be given as long as a clinical benefit is evident In patients with advanced liver disease maintenance treatment is recommended by most experts
In pivotal phase II studies in which patients were treated with BLV for 24-48 weeks some patients 10-20 maintained a reduced HDV viral load with normal liver enzymes after the end of treatment Wedemeyer et al 2018 2019 2020 However it is completely unclear which patients are able to control HDV infection without antiviral therapies Biomarkers would be needed to identify patients in whom treatment can stopped safely This is even more important because HDV flares can be life-threatening in the event of a relapse after stopping BLV Thus the main aim of this study is to explore biomarkers in blood and liver associated with maintained virological control after at least 24 weeks of HDV-RNA levels below 100 IUml with at least 2 tests plus one test at screening on BLV treatment The investigators hypothesize that biomarker-based criteria should be able to identify patients with a sustained immune control This information would be highly relevant to personalize treatment duration or stopping of BLV treatment could reduce long-term disease burden would enable safer treatments and also reduce treatment costs Within the proposed systematic unbiased study the investigators follow a broad screening for biomarkers that may be suitable to discriminate in a first step between patients that will experience a virological relapse HDV RNA above 1000 IUml after discontinuation of treatment and those without
The investigators plan to include 20 patients in this study These patients have to have received BLV treatment for at least 48 weeks and have to show HDV-RNA levels below 100 IUml in two repeated tests plus one test at screening for at least 24 weeks while still being on treatment Treatment will be stopped with the beginning of the study and patients will be followed for 48 weeks It is expected that up to 14 patients will maintain HDV-RNA control HDV-RNA below 1000 IUml The other patients are expected to experience a virological relapse Treating physicians should consider to re-initiate BLV at HDV-RNA levels of above 1000 IUml
The aim of the study is to identify biomarkers that are associated with maintained virological response and could therefore be further investigated as predictive markers for treatment response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None